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In the present study, chitosan (CS) and pectin (PEC) were utilized for the preparation of 3D printable inks through pneumatic extrusion for biomedical applications. CS is a polysaccharide with beneficial properties; however, its printing behavior is not satisfying, rendering the addition of a thickening agent necessary, i.e., PEC. The influence of PEC in the prepared inks was assessed through rheological measurements, altering the viscosity of the inks to be suitable for 3D printing. 3D printing conditions were optimized and the effect of different drying procedures, along with the presence or absence of a gelating agent on the CS-PEC printed scaffolds were assessed. The mean pore size along with the average filament diameter were measured through SEM micrographs. Interactions among the characteristic groups of the two polymers were evident through FTIR spectra. Swelling and hydrolysis measurements confirmed the influence of gelation and drying procedure on the subsequent behavior of the scaffolds. Ascribed to the beneficial pore size and swelling behavior, fibroblasts were able to survive upon exposure to the ungelated scaffolds.

The substantial improvements and innovations in communication networks and bio-medical technologies have led to the adoption of networked medical devices due to which the attack surface has increased profoundly. Numerous devices in practice were designed and developed years ago without security measures. In such a scenario, the role of regulatory bodies has become evident. The Food and Drug Administration (FDA) validates and approves devices before commercialization. In contrast, the European Union (EU) follows a decentralized approach and Notified Bodies (NB) for assuring high standards, safety and quality of medical devices being marketed in Europe. Once the device has gone through stringent regulations including good manufacturing practices, Quality Management System (QMS), labeling, clinical tests, performance standards, adequate storage and packaging practices, a declaration of conformity will be granted, which is a legal binding document stating that the device is conformant with applicable European requirements and can be marketed in Europe. However, such regulations lack a systematic methodology to determine unified security, safety and privacy risk that eventually influence the health of patients. To cover these gaps, this research proposes Integrated Safety, Security, and Privacy (ISSP) Risk Assessment Framework to determine the risk level of the device and required security controls. It is, then applied to a case scenario of an infusion pump and further evaluated by comparing it with current standards and practices. The comparison shows that the framework provides a unified approach to consider different types of risks associated with devices.

Chitosan can form interpolymer complexes (IPCs) with anionic polymers to form biomedical platforms (BMPs) for wound dressing/healing applications. This has resulted in its application in various BMPs such as gauze, nano/microparticles, hydrogels, scaffolds, and films. Notably, wound healing has been highlighted as a noteworthy application due to the remarkable physical, chemical, and mechanical properties enabled though the interaction of these polyelectrolytes. The interaction of chitosan and anionic polymers can improve the properties and performance of BMPs. To this end, the approaches employed in fabricating wound dressings was evaluated for their effect on the property-performance factors contributing to BMP suitability in wound dressing. The use of chitosan in wound dressing applications has had much attention due to its compatible biological properties. Recent advancement includes the control of the degree of crosslinking and incorporation of bioactives in an attempt to enhance the physicochemical and physicomechanical properties of wound dressing BMPs. A critical issue with polyelectrolyte-based BMPs is that their effective translation to wound dressing platforms has yet to be realised due to the unmet challenges faced when mimicking the complex and dynamic wound environment. Novel BMPs stemming from the IPCs of chitosan are discussed in this review to offer new insight into the tailoring of physical, chemical, and mechanical properties via fabrication approaches to develop effective wound dressing candidates. These BMPs may pave the way to new therapeutic developments for improved patient outcomes.

Medical device industry encompasses a wide range of technologies and applications, which makes the process validation approach (IQ/OQ/PQ framework) and OQ/PQ implementation method difficult to be defined in the industry's regulation and process validation guidance documents. Based on two-level (component production level and device assembly level) process validation approach, this article proposes 1) a typical section structure & contents for production equipment/system/process validation OQ/PQ protocols, 2) a typical subsection structure & contents for the protocols' most critical section - Test Plan, and 3) the validation approach and OQ Detailed Test Plan for both common equipment and test equipment.

Background: In most clinical laboratories, examination quality is considered excellent, whereas pre-/postexamination quality is an area for focused improvement. In our organization, 1 pre-/postexamination quality metric, namely, lost specimens, as tracked continuously for 27 years, has demonstrated steady improvement. During this period, many of our processes transitioned to highly automated effectors. Concurrently, we implemented behavioral controls and reengineered error-prone processes. We believe that this bilateral approach has conclusively lowered our lost specimen rates., Methods: Using data spanning 27 years, we plotted the correlation between lost specimens and the implementation dates for 8 major phases of automation, as well as 19 process improvements and engineering controls., Results: The lost specimen rate decreased nearly 100-fold. In Six Sigma terms, the 12 month moving average for lost specimens currently hovers at approximately 5.94 sigma, with 11 months at or better than 6 sigma. Although the combination of implementation of process improvements, engineering controls, and automation contributed to the reduction, automation was the most significant contributor., Conclusions: The custom automation in use by our laboratory has led to improved pre-/postexamination quality. Although this automation may not be possible for all laboratories, our description of 19 behavior and engineering controls may be useful to others seeking to design high quality pre-/postexamination processes., (© American Society for Clinical Pathology 2019. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

The Australasian College of Physical Scientists and Engineers in Medicine (ACPSEM) Radiation Oncology Specialty Group (ROSG) formed a series of working groups to develop recommendations for guidance of radiation oncology medical physics practice within the Australasian setting. These recommendations provide a standard for safe work practices and quality control. It is the responsibility of the medical physicist to ensure that locally available equipment and procedures are sufficiently sensitive to establish compliance. The recommendations are endorsed by the ROSG, have been subject to independent expert reviews and have also been approved by the ACPSEM Council. For the Australian audience, these recommendations should be read in conjunction with the Tripartite Radiation Oncology Practice Standards and should be read in conjunction with relevant national, state or territory legislation which take precedence over the ACPSEM publication Radiation Oncology Reform Implementation Committee (RORIC) Quality Working Group, RANZCR, 2011a; Kron et al. Clin Oncol 27(6):325-329, 2015; Radiation Oncology Reform Implementation Committee (RORIC) Quality Working Group, RANZCR, 2018a, b).

Background: Improvement of medical content in Biomedical Engineering curricula based on a qualitative assessment process or on a comparison with another high-standard program has been approached by a number of studies. However, the quantitative assessment tools have not been emphasized. The quantitative assessment tools can be more accurate and robust in cases of challenging multidisciplinary fields like that of Biomedical Engineering which includes biomedicine elements mixed with technology aspects. The major limitations of the previous research are the high dependence on surveys or pure qualitative approaches as well as the absence of strong focus on medical outcomes without implicit confusion with the technical ones. The proposed work presents the development and evaluation of an accurate/robust quantitative approach to the improvement of the medical content in the challenging multidisciplinary BME curriculum., Methods: The work presents quantitative assessment tools and subsequent improvement of curriculum medical content applied, as example for explanation, to the ABET (Accreditation Board for Engineering and Technology, USA) accredited biomedical engineering BME department at Jordan University of Science and Technology. The quantitative results of assessment of curriculum/course, capstone, exit exam, course assessment by student (CAS) as well as of surveys filled by alumni, seniors, employers and training supervisors were, first, mapped to the expected students' outcomes related to the medical field (SOsM). The collected data were then analyzed and discussed to find curriculum weakness points by tracking shortcomings in every outcome degree of achievement. Finally, actions were taken to fill in the gaps of the curriculum. Actions were also mapped to the students' medical outcomes (SOsM)., Results: Weighted averages of obtained quantitative values, mapped to SOsM, indicated accurately the achievement levels of all outcomes as well as the necessary improvements to be performed in curriculum. Mapping the improvements to SOsM also helps in the assessment of the following cycle., Conclusion: The suggested assessment tools can be generalized and extended to any other BME department. Robust improvement of medical content in BME curriculum can subsequently be achieved.

Evaluation of medical devices via clinical trial is often a necessary step in the process of bringing a new product to market. In recent years, device manufacturers are increasingly using stochastic engineering models during the product development process. These models have the capability to simulate virtual patient outcomes. This article presents a novel method based on the power prior for augmenting a clinical trial using virtual patient data. To properly inform clinical evaluation, the virtual patient model must simulate the clinical outcome of interest, incorporating patient variability, as well as the uncertainty in the engineering model and in its input parameters. The number of virtual patients is controlled by a discount function which uses the similarity between modeled and observed data. This method is illustrated by a case study of cardiac lead fracture. Different discount functions are used to cover a wide range of scenarios in which the type I error rates and power vary for the same number of enrolled patients. Incorporation of engineering models as prior knowledge in a Bayesian clinical trial design can provide benefits of decreased sample size and trial length while still controlling type I error rate and power.

Objective: The overall goal of this paper is to demonstrate that dissemination of models and analyses for assessing the reproducibility of simulation results can be incorporated in the scientific review process in biomechanics., Methods: As part of a special issue on model sharing and reproducibility in the IEEE Transactions on Biomedical Engineering, two manuscripts on computational biomechanics were submitted: Rajagopal et al., IEEE Trans. Biomed. Eng., 2016 and Schmitz and Piovesan, IEEE Trans. Biomed. Eng., 2016. Models used in these studies were shared with the scientific reviewers and the public. In addition to the standard review of the manuscripts, the reviewers downloaded the models and performed simulations that reproduced results reported in the studies., Results: There was general agreement between simulation results of the authors and those of the reviewers. Discrepancies were resolved during the necessary revisions. The manuscripts and instructions for download and simulation were updated in response to the reviewers' feedback; changes that may otherwise have been missed if explicit model sharing and simulation reproducibility analysis was not conducted in the review process. Increased burden on the authors and the reviewers, to facilitate model sharing and to repeat simulations, were noted., Conclusion: When the authors of computational biomechanics studies provide access to models and data, the scientific reviewers can download and thoroughly explore the model, perform simulations, and evaluate simulation reproducibility beyond the traditional manuscript-only review process., Significance: Model sharing and reproducibility analysis in scholarly publishing will result in a more rigorous review process, which will enhance the quality of modeling and simulation studies and inform future users of computational models.

This paper provides a brief history of the U.S. funding initiatives associated with promoting multiscale modeling of the physiome since 2003. An effort led in the United States is the Interagency Modeling and Analysis Group (IMAG) Multiscale Modeling (MSM) Consortium. Though IMAG and the MSM Consortium have generated much interest in developing MSM models of the physiome, challenges associated with model and data sharing in biomedical, biological, and behavioral systems still exist. Since 2013, the IEEE EMBS Technical Committee on Computational Biology and the Physiome (CBaP TC) has supported discussions on promoting model reproducibility through publications. This special issue on model sharing and reproducibility is a realization of the CBaP TC discussions. Though open questions remain on how we can further facilitate model reproducibility, accessibility, and reuse by the worldwide community for different biomedical domain applications, this special issue provides a unique demonstration of both the challenges and opportunities for publishing reproducible computational models.

This article, approved by the Rehabilitation Engineering & Assistive Technology Society of North America Board of Directors on December 23, 2013, shares typical clinical applications and provides evidence from the literature supporting the use of wheelchair standers.

Background: The percutaneous endoscopic gastrostomy (PEG) is a ubiquitous feeding tube with high rates of accidental dislodgement, with significant morbidity and health care costs. We hypothesized use of a decoupling device is a safe and effective mechanism to reduce dislodgements., Study Design: We studied a prospective cohort of 100 patients from an academic center. Enrollment included patients requiring PEG tube placement with follow up extending through an individual's lifetime use of their PEG tube. The primary endpoint was accidental dislodgement of the principally placed PEG tube. The secondary endpoint was time to accidental dislodgement of the PEG tube., Results: All 100 patients received the SafetyBreak device and had complete follow-up. Half of the patients had at least a single episode of device decoupling, indicating prevention of dislodgement of the PEG. Eight patients ultimately had dislodgement, resulting in a significantly lower dislodgement rate when compared with a historical cohort (P = .036) and significantly longer survival of the PEG (log rank = 0.005). When compared with a concurrent cohort (without the device) there was also significantly lower dislodgement rate (P = .03) and a trend toward longer survival of the PEG (log rank = 0.08)., Conclusions: When compared with both a historical and concurrent cohort of patients, the SafetyBreak device reduces accidental dislodgement of PEG tubes. As an increasing number of PEGs are being placed, an increasing number of patients are at risk for dislodgement. The SafetyBreak device is an innovative, economical solution to the problem of accidental dislodgement of the PEG tube., (© The Author(s) 2015.)

The Point of Care (PoC) version of the interoperability standard ISO/IEEE11073 (X73) provided a mechanism to control remotely agents through documents X73-10201 and X73-20301. The newer version of X73 oriented to Personal Health Devices (PHD) has no mechanisms to do such a thing. The authors are working toward a common proposal with the PHD Working Group (PHD-WG) in order to adapt the remote control capabilities from X73PoC to X73PHD. However, this theoretical adaptation has to be implemented and tested to evaluate whether or not its inclusion entails an acceptable overhead and extra cost. Such proof-of-concept assessment is the main objective of this paper. For the sake of simplicity, a weighing scale with a configurable operation was chosen as use case. First, in a previous stage of the research - the model was defined. Second, the implementation methodology - both in terms of hardware and software - was defined and executed. Third, an evaluation methodology to test the remote control features was defined. Then, a thorough comparison between a weighing scale with and without remote control was performed. The results obtained indicate that, when implementing remote control in a weighing scale, the relative weight of such feature represents an overhead of as much as 53%, whereas the number of Implementation Conformance Statements (ICSs) to be satisfied by the manufacturer represent as much as 34% regarding the implementation without remote control. The new feature facilitates remote control of PHDs but, at the same time, increases overhead and costs, and, therefore, manufacturers need to weigh this trade-off. As a conclusion, this proof-of-concept helps in fostering the evolution of the remote control proposal to extend X73PHD and promotes its inclusion as part of the standard, as well as it illustrates the methodological steps for its extrapolation to other specializations., (Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.)

Since 1974, the Bachelor of Biomedical Engineering Program (BBME) is offered at Universidad Autónoma Metropolitana-Iztapalapa, in Mexico City. By design, it must be completed in four years (12 trimesters) and, in the latter three, the senior students work on a BME project, which is done by completing three modules: Project Seminar (PS), Project on BME I and Project on BME II. In the PS module, the student must find a problem of interest in the BME field and suggest a solution through the development of an Engineering Project Proposal (EPP). Currently, the module is being taught by two faculty members of the BBME, who instruct students on how to develop their EPPs and evaluate their progress by reviewing a number of EPPs during the trimester. This generates a huge workload for the module instructors, which makes it necessary to involve more faculty members trimester-to-trimester (i.e. every 12 weeks) and, therefore, to create a set of systematic guidelines that ease the evaluation process for new instructors. Hence, the purpose of this paper is to present an assessment strategy (in the form of an assessment matrix) for the PS module as well as some preliminary results after two trimesters of its implementation.

Preventive maintenance is a core function of clinical engineering, and it is essential to guarantee the correct functioning of the equipment. The management and control of maintenance activities are equally important to perform maintenance. As the variety of medical equipment increases, accordingly the size of maintenance activities increases, the need for better management and control become essential. This paper aims to develop a new model for preventive maintenance priority of medical equipment using quality function deployment as a new concept in maintenance of medical equipment. We developed a three-domain framework model consisting of requirement, function, and concept. The requirement domain is the house of quality matrix. The second domain is the design matrix. Finally, the concept domain generates a prioritization index for preventive maintenance considering the weights of critical criteria. According to the final scores of those criteria, the prioritization action of medical equipment is carried out. Our model proposes five levels of priority for preventive maintenance. The model was tested on 200 pieces of medical equipment belonging to 17 different departments of two hospitals in Piedmont province, Italy. The dataset includes 70 different types of equipment. The results show a high correlation between risk-based criteria and the prioritization list.

Advances in neurotechnology will raise new ethical dilemmas, to which scientists and the rest of society must respond. Here I present a "toolbox" of concepts to help us analyze these issues and communicate with each other about them across differences of ethical intuition., (Copyright © 2015 Elsevier Inc. All rights reserved.)

For decades, BME has been touted worldwide as the rising star in engineering disciplines. The number of technological advancements that can be credited to the field since the 1950s is staggering, ranging from new biomedical diagnostics and therapeutics to sensors, imaging technology, and orthopedics. In the United States, job numbers are on a steady rise and expected to grow by 27% within the next ten years, according to the U.S. Bureau of Labor Statistics. In those terms, "there has never been a better, more exciting time to enter the field," says Bruce Wheeler (Figure 1), former president of the IEEE Engineering in Medicine and Biology Society and a BME professor at the University of Florida in Gainesville.

This white paper provides a perspective of the challenges, research needs, and future directions for control systems engineering in continuous pharmaceutical processing. The main motivation for writing this paper is to facilitate the development and deployment of control systems technologies so as to ensure quality of the drug product. Although the main focus is on small-molecule pharmaceutical products, most of the same statements apply to biological drug products. An introduction to continuous manufacturing and control systems is followed by a discussion of the current status and technical needs in process monitoring and control, systems integration, and risk analysis. Some key points are that: (1) the desired objective in continuous manufacturing should be the satisfaction of all critical quality attributes (CQAs), not for all variables to operate at steady-state values; (2) the design of start-up and shutdown procedures can significantly affect the economic operation of a continuous manufacturing process; (3) the traceability of material as it moves through the manufacturing facility is an important consideration that can at least in part be addressed using residence time distributions; and (4) the control systems technologies must assure quality in the presence of disturbances, dynamics, uncertainties, nonlinearities, and constraints. Direct measurement, first-principles and empirical model-based predictions, and design space approaches are described for ensuring that CQA specifications are met. Ways are discussed for universities, regulatory bodies, and industry to facilitate working around or through barriers to the development of control systems engineering technologies for continuous drug manufacturing. Industry and regulatory bodies should work with federal agencies to create federal funding mechanisms to attract faculty to this area. Universities should hire faculty interested in developing first-principles models and control systems technologies for drug manufacturing that are easily transportable to industry. Industry can facilitate the move to continuous manufacturing by working with universities on the conception of new continuous pharmaceutical manufacturing process unit operations that have the potential to make major improvements in product quality, controllability, or reduced capital and/or operating costs. Regulatory bodies should ensure that: (1) regulations and regulatory practices promote, and do not derail, the development and implementation of continuous manufacturing and control systems engineering approaches; (2) the individuals who approve specific regulatory filings are sufficiently trained to make good decisions regarding control systems approaches; (3) provide regulatory clarity and eliminate/reduce regulatory risks; (4) financially support the development of high-quality training materials for use of undergraduate students, graduate students, industrial employees, and regulatory staff; (5) enhance the training of their own technical staff by financially supporting joint research projects with universities in the development of continuous pharmaceutical manufacturing processes and the associated control systems engineering theory, numerical algorithms, and software; and (6) strongly encourage the federal agencies that support research to fund these research areas., (© 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.)